Voice-preserving Treatment of Laryngeal Papilloma
RRP and its surgeries usually involves the vocal cords or other regions of the larynx,
thereby, resulting in a poor voice. Our previous studies have shown the efficacy and safety
of a microvascular targeting technique (MVT) for RRP treatment using the 585 nm PDL. This
technique provides a less traumatic alternative to surgery. However, postoperative
recurrence of lesions still remains a problem because of microvascular regrowth. This study
is a continuation of our effort to develop a new and less traumatic treatment for RRP. In
this study, we will develop a new, combined RRP treatment with PDL and Celebrex. We will
determine if Celebrex, a newly developed inhibitor of COX-2, can provide a long-term
inhibitory effect on RRP through its anti-angiogenic activity and the synergic effect
produced with the laser therapy. The hypothesis is that postoperative administration of
Celebrex will provide a long-term inhibitory effect on microvascular regrowth and on COX-2
enzyme, thereby, preventing RRP from recurring after the PDL therapy. Our specific aim in
this study is to determine the synergic effect between PDL and Celebrex and long-term
efficacy of Celecoxib in preventing postoperative RRP recurrence. We will compare this new
combined strategy with traditional treatments in 30 adult patients. This is the first time
to combined this new laser MVT technique with a COX-2 inhibitor for microvascular targeting
therapy of RRP. This combined strategy, if successful in this proposed study, will provide a
new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in
managing RRP and will be safe and convenient enough for use in out-patient treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Case With Papilloma Recurrence During a 12-month Follow up
Criteria for the recurrence: the site scoring >4, plus visible lesion found in >50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.
12-month follow up
No
Wang Zhi, M.D
Principal Investigator
Boston Medical Center
United States: Institutional Review Board
RDC-006617A
NCT00592319
May 2005
July 2009
Name | Location |
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Boston Medical Center | Boston, Massachusetts 02118 |